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PRINCETON, N.J. - Grace Therapeutics, Inc. (NASDAQ:GRCE), a biopharmaceutical company specializing in treatments for rare diseases with a market capitalization of $25.65 million, recently held a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss their New Drug Application (NDA) for GTx-104. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet. The injectable form of nimodipine is designed for intravenous (IV) infusion in patients with aneurysmal subarachnoid hemorrhage (aSAH), a form of stroke characterized by bleeding over the brain's surface.
In the meeting, the FDA reviewed the Phase 3 STRIVE-ON safety trial data for GTx-104 and provided guidance on the NDA submission, which the company expects to file in the second quarter of 2025. The trial data suggested that GTx-104 reduced the incidence of clinically significant hypotension by 19% compared to oral nimodipine, with 54% of patients maintaining a relative dose intensity of 95% or higher. Additionally, the trial indicated better functional outcomes and a lower pharmacoeconomic burden with GTx-104.
The STRIVE-ON trial, which compared GTx-104 with oral nimodipine in aSAH patients, met its primary endpoint. The study involved 50 patients receiving GTx-104 and 52 patients treated with oral nimodipine. GTx-104 also showed fewer ICU readmissions and ventilator days, with comparable adverse events between the two treatment arms.
Grace Therapeutics' CEO, Prashant Kohli, expressed confidence in the alignment with the FDA on their NDA submission for GTx-104, highlighting the potential to deliver the first significant innovation in aSAH treatment in nearly four decades.
The company's proprietary nanoparticle technology allows for the aqueous formulation of insoluble nimodipine for standard peripheral IV infusion, potentially eliminating the need for nasogastric tube administration in unconscious or dysphagic patients. With a current ratio of 6.06, InvestingPro analysis shows the company maintains strong short-term financial stability, though it faces challenges with cash burn rates. This could also reduce food effects, drug-to-drug interactions, and dosing errors, while better managing hypotension in aSAH patients.
Grace Therapeutics, which focuses on drug candidates for rare and orphan diseases, has garnered Orphan Drug Designation for its lead clinical assets, including GTx-104, promising seven years of marketing exclusivity in the U.S. post-launch. While the stock currently trades near its 52-week low, analysts maintain optimistic price targets, with InvestingPro indicating potential upside based on Fair Value calculations. Subscribers can access 11 additional ProTips and comprehensive financial metrics to better evaluate GRCE's investment potential. This article is based on a press release statement from Grace Therapeutics.
In other recent news, Grace Therapeutics has reported positive results from its Phase 3 STRIVE-ON safety trial for GTx-104, an intravenous formulation of nimodipine. The trial, which included 102 patients with aneurysmal Subarachnoid Hemorrhage (aSAH), demonstrated a 19% reduction in hypotension episodes compared to the oral version of the drug. Moreover, 54% of patients in the GTx-104 group achieved a relative dose intensity of 95% or higher, significantly surpassing the 8% achieved by those on oral nimodipine. Grace Therapeutics plans to submit a New Drug Application for GTx-104 in the first half of 2025. In addition, the company has secured up to $30 million in financing, led by Nantahala Capital and ADAR1 Partners, LP, with $15 million already received. The funds will support the pre-commercial development of GTx-104 and general corporate purposes. H.C. Wainwright has reiterated its Buy rating for Grace Therapeutics, maintaining a $12 price target following the positive trial results and financing announcement. The firm highlights the favorable safety profile of GTx-104 and its potential market advantages over existing treatments.
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